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HEALTHCARE COMPLIANCE 2 – RESEARCH FACILITIES

HEALTHCARE COMPLIANCE 2 – RESEARCH FACILITIES

1.What are some of the reasons that the Federal government wishes to regulate research institutions?

2. The NIH has published mandatory standards designed to ensure that the design, conduct, and reporting of research funded by it will be free from bias resulting from investigator financial conflicts of interest.There are two terms critical to the understanding of those standards. Define“financial conflict of interest” and “significant financial interest”.

3. The competition for funding to support research is intense. In FY 2011, only 18% of NIH grant applicants were successful. This sometimes leads researchers to behave in unethical ways – to engage in research misconduct. What is the definition of “research misconduct”?

4. After the Office of Research Integrity (ORI) has completed its review of alleged research misconduct, it has several optional actions that it can take. What are three of them? (list)

5. To what does the regulation entitled the Basic HHS Policy for Protection of Human Research Subjects (also known as the Common Rule )apply?

(I provided powerpoint to help, please see attachment)

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